MAUDE Adverse Event Report: C2DX INC. T PUMP; Pack, hot or cold, water circulating

Model Number TP700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 03/14/2024

Event Type  Injury  

Event Description

Customer statement: the patient obtained a partial thickness burn on the left arm.The pump was set to continuous mode and 100° f.The t/pump was running and the patient was on the tpad for a total of [?] 3 hours (12:47-15:55 on march 14th) during prep, surgery, and in recovery.The patient was laying on the tpad on his left side, his left leg and arm making contact with the pad.The blood pressure cuff was placed just above the pad and gave some heightened readings as the surgery progressed.The patient's arm skin was checked once by the crn on the case by feel and felt warm but did not show signs, from touch, of burning.It was noted that the patient had "very fine" skin and there were two layers of cloth between the skin and the pad.It was discovered after the surgery and removal of the tpad that the patient's arm skin was purple, and blisters developed within the hour which coincided with the pattern of the pad.The patient's leg skin, where the pad was in contact, was also red upon removal, but did not develop any burns and returned to its normal color.

Manufacturer Narrative

Per the device ifu: rechecking the patient's skin condition: recheck the entire area of the patient's skin condition that is in contact with the pad at least every 30 minutes.Note any change in the skin integrity that relates to: excessive moisture - dry the skin surface by wiping away the moisture.Color of the epidermis skin texture - patient's skin condition is acceptable to continue therapy evaluation report is attached.

• Brand Name: T PUMP
• Type of Device: Pack, hot or cold, water circulating
• Manufacturer (Section D): C2DX INC.; 555 e eliza st suite a; schoolcraft MI 49087
• MDR Report Key: 18977510
• MDR Text Key: 338568829
• Report Number: 3015489752-2024-00002
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TP700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male